Root Caries Excavation with Air Water/powder Prophylaxis Device for ART Restorations

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 65 years and older
• All sexes
• Healthy volunteers accepted
• Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Excavation of Root Caries with Air-water Powder Stream Vs Manual Excavation for Atraumatic Restorative Treatment in Older Patients: a Single-blind Randomized Controlled Trial

Conditions

Dental Caries Extending Into Dentin, Root Caries

Being tested

Control: Hand instrumentation for caries excavation, Intervention 1: EMS Airflow device for caries excavation, Intervention 2: Hand excavation + EMS Airflow device for caries excavation

Keywords

Root caries, Elders, Atraumatic restorative treatment, Glass-ionomer cement

Medical subject headings

Root Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Control: Hand instrumentation for caries excavationProcedure or surgery

  Also called Hand instrumentation for caries excavation

  An enamel hatchet will be used to create access to the carious lesion and then removal of soft carious tissue will be undertaken with excavators. Excavation will be stopped when some resistance to excavation will be felt and the cavity will be then conditioned with polyacrylic acid for 20 s, washed and dried with cotton pellets. A high-viscosity glass-ionomer cement will be used to restore the cavity. Moisture control will be achieved with the use of cotton wool rolls. A chair-side assistant will hand-mix the glass-ionomer according to manufacturers' instructions and it will be placed in the cavity using the "press-finger" technique whenever the type of cavity allows it. In the case of root restorations, a glove coated with petroleum jelly will be used similarly to the "press-finger" technique to better condense the material into the cavity. Excess material will be removed; the restoration will be coated with petroleum jelly. No local anaesthetic will be used to provide ART treatment.

• Intervention 1: EMS Airflow device for caries excavationProcedure or surgery

  Also called Powder/water jet prophylaxis device (EMS Airflow) for caries excavation

  An enamel hatchet will first be used to gain access into the cavity. Then the powder-water prophylaxis device will be used for the removal of soft carious tissue with the sodium bicarbonate powder-water jet. Excavation will be stopped when the colour of the lesion begins to darken and all the soft deposits are evacuated. The excavation will be done intermittently allowing sufficient time to check with hand instrument the surface hardness of the lesion. If the lesion is still soft excavation will be continued until the surface is hard suitable for restoring. The cavity will be then rinsed with copious water spray to evacuate all the powder-water material. The restoration procedure with a glass-ionomer cement will be done following the same procedures as in the control group.

• Intervention 2: Hand excavation + EMS Airflow device for caries excavationProcedure or surgery

  Also called Hand excavation and Powder/ jet prophylaxis device (EMS Airflow) for caries excavation

  The participants allocated to this group will have the caries excavated as described for the control group. Then prior to filling the excavated cavity, the procedure of sodium bicarbonate powder-water jet irrigation as described for the intervention group #1 will be performed to condition the prepared excavated cavity. Then the restorative procedure will be completed with the restorative material and procedures as described for the previous groups.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Restoration Success rate

   Restoration success rate (SxR %): For the purpose of this trial, a successful restoration is defined as one that has undergone no changes in its surface / structural integrity, still adhered to the structure and is functional when examined during the scheduled or unscheduled recall visit. The restoration success rate (SxR %) is calculated by the number of successful restorations present at the end of the trial (nsx) divided by the number of restorations placed in the beginning of the trial (N0) multiplied by 100 using the formula: SxR % = (nsx / N0) * 100.

   Measured: 1 year, year 1

2. Restoration survival rate

   Restoration survival rate (SvR %): For the purpose of this trial, any restoration, where the surface or structural integrity is compromised, but still adhering to the tooth, is functional and does not warrant a repair or replacement when examined during the scheduled or unscheduled recall visit, is considered survived. The restoration survival rate (SvR %) is calculated by the number of survived restorations present at the end of the trial (nsv) divided by the number of restorations placed in the beginning of the trial (N0) multiplied by 100 using the formula: SvR = (nsv / N0) * 100.

   Measured: 1 year, year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted30 Mar 2021
2. Study start30 Sep 2021
3. Primary completionSep 2025 (estimated)
4. Study completion31 Dec 2025 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Dental Caries Extending Into DentinStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.